The PREWEAN Study. Weaning of Preterm Infants During the First Year of Life.

NCT02936219 | Active Not Recruiting

• 1 other identifier: PREWEAN
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

In this Austrian observational study preterm infants born with a birth weight \<1500 g and a gestational age \<32 weeks will be investigated at the neonatal outpatient clinic. Infants will be stratified according their feeding regimen (breast, formula and combined feeding) and their introduction of solid foods (early complementary feeding group: \<17th week of life corrected for prematurity, late complementary feeding group: ≥17th week of life corrected for prematurity). Nutrient intakes and anthropometric parameters will be assessed at term, 6 weeks, 12 weeks, 6 months, 9 months and 12 months - all corrected for prematurity and with 40, 54 and 66 months.

Conditions

Growth Failure; Atopy; Adiposity; Cognitive Impairment; Neurological Impairment

Keywords

complementary feeding; breast milk; formula feeding; combined feeding; preterm infants; body composition

Outcome Measures

Primary Outcomes (1)

• Is there a height difference of 5% at one year of age corrected for prematurity between different complementary feeding groups?

  Is there a height difference of 5% at one year of age corrected for prematurity

  The patients will be recruited in the period of 04/2016 till 06/2021. The primary observation period is one year.The follow up period lasts until 06/2025

Secondary Outcomes (6)

• Atopy

  04/2016 till 06/2025

• Body composition

  04/2016 till 06/2025

• Neurodevelopmental outcome with 1 and 2 years

  04/2017 till 06/2025

• Neurodevelopmental outcome with 4,5 and 5,5 years

  04/2017 till 06/2025

• weight

  04/2016-06/2025

Study Arms (6)

Early complementary breast feeding

The EARLY complementary feeding group is defined as the introduction of complementary food \<17th week of life corrected for term. In addition, infants are stratified to the milk regime, like human milk feeding, at the study enrollment.

Early complementary combined feeding

The EARLY complementary feeding group is defined as the introduction of complementary food \<17th week of life corrected for term. In addition, infants are stratified to the milk regime, like combined milk feeding, at the study enrollment.

Early complementary formula feeding

The EARLY complementary feeding group is defined as the introduction of complementary food \<17th week of life corrected for term. In addition, infants are stratified to the milk regime, like formula feeding, at the study enrollment.

Late complementary breast feeding

The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like human milk feeding, at the study enrollment.

Late complementary combined feeding

The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like combined milk feeding, at the study enrollment.

Late complementary formula feeding

The LATE complementary feeding group is defined as the introduction of complementary food ≥17th week of life corrected for term. In addition, infants are stratified to the milk regime, like formula feeding, at the study enrollment.

Eligibility Criteria

• Age: 1 Week - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born with a birth weight \<1500g and a gestational age \<32 weeks

You may qualify if:

• Preterm infants born with a birth weight \<1500g and a gestational age \<32 weeks
• Informed consent

You may not qualify if:

• Gastrointestinal diseases: e.g. Hirschsprung disease
• Congenital heart diseases
• Major congenital birth defects
• Chromosomal aberrations

Sponsors & Collaborators

• Medical University of Vienna: lead
• Wilhelminenspital Vienna: collaborator
• Kaiser Franz Josef Hospital: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Failure to Thrive; Obesity; Cognitive Dysfunction; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases

Study Officials

• Nadja Haiden

  Medical University of Vienna, 1090 Vienna, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoz. Prof. PD. Dr. Nadja Haiden, MSc

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 18, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 7, 2022

Record last verified: 2022-04

Locations

AU (1)